Cleared Traditional

VIGOR COMPRESSION HIP SCREW SYSTEM (K962644) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K962644 · Deutschland Surgical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
60d
Days
Class 2
Risk

K962644 is an FDA 510(k) clearance for the VIGOR COMPRESSION HIP SCREW SYSTEM. Classified as Device, Fixation, Proximal Femoral, Implant (product code JDO), Class II - Special Controls.

Submitted by Deutschland Surgical, Inc. (Dallas, US). The FDA issued a Cleared decision on September 6, 1996 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Deutschland Surgical, Inc. devices

Submission Details

510(k) Number K962644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1996
Decision Date September 06, 1996
Days to Decision 60 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 122d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDO Device, Fixation, Proximal Femoral, Implant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JDO Device, Fixation, Proximal Femoral, Implant

All 15
Devices cleared under the same product code (JDO) and FDA review panel - the closest regulatory comparables to K962644.
INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW
K080434 · Smith & Nephew, Inc. · Apr 2008
SYNTHES (USA) DHS HELIX SYSTEM
K981757 · Synthes (Usa) · Jul 1998
SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION
K964259 · Synthes (Usa) · Jan 1997
TITANIUM LIMITED CONTACT DYNAMIC HIP SCREW PLATE (TILC-DHS)
K953607 · Synthes (Usa) · Mar 1996
SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX]
K951904 · Synthes (Usa) · Jul 1995
SYNTHES LIMITED CONTACT-DYNAMIC HIP SCREW IMPLANT
K923613 · Synthes (Usa) · Jun 1993